Quoin Pharmaceuticals: Netherton Syndrome Drug Application in Japan

Quoin Pharmaceuticals Receives Positive Regulatory Signals for Netherton Syndrome Treatment in Japan

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) has received confirmation from Japan’s Ministry of Health, Labor and Welfare (MHLW) that its led product candidate, QRX003, qualifies for both Orphan Drug Designation (ODD) and Fast Track regulatory review for teh treatment of netherton Syndrome, a rare and debilitating genetic skin disorder. This positive progress, announced January 27, 2026, paves the way for potential accelerated development and commercialization of QRX003 in Japan, a key market for the company.

The MHLW’s ODD program grants special status to therapies targeting rare diseases affecting fewer than 50,000 people in Japan. This designation offers a range of benefits, including research and development subsidies, tax credits for clinical testing, reduced application fees, priority review, and crucially, ten years of market exclusivity upon approval. According to a company release, QRX003 is now positioned to perhaps become the first approved treatment for Netherton Syndrome in Japan.

Did you know? – Netherton Syndrome is caused by mutations in the SPINK5 gene, leading to a defective skin barrier and severe skin inflammation. It affects approximately 1 in 100,000 births.

“Following a successful meeting with MHLW, we are optimistic that QRX003 will be granted ODD status in Japan,” stated Dr. Michael Myers, CEO of quoin Pharmaceuticals. “We are also pleased to learn that MHLW has confirmed QRX003 will also qualify for Fast Track regulatory review status in Japan.”

This regulatory progress coincides with Quoin’s plans to establish a Japanese subsidiary to facilitate self-commercialization of QRX003, should it receive approval. japan represents one of three core commercial territories for Quoin, alongside the United States and the European Union, where QRX003 previously secured Orphan Drug Designation in 2025.

Currently, QRX003 lotion (4%) is undergoing evaluation in two late-stage, pivotal clinical trials for Netherton Syndrome.Enrollment in these trials is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of the same year. The company plans to submit a New Drug Application (NDA) later in 2026 or in early 2027.

Pro tip – Fast Track designation in Japan can expedite the review process,potentially shortening the time to market for promising new therapies.

Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of therapies for rare and orphan diseases. The company’s pipeline extends beyond Netherton Syndrome, encompassing potential treatments for conditions such as Peeling Skin Syndrome, Palmoplantar keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, and Angiofibroma. more facts about quoin Pharmaceuticals and its pipeline can be found at www.quoinpharma.com or on LinkedIn.

Investors interested in learning more are encouraged to contact PCG Advisory’s Jeff Ramson at [email protected] or [phone].

---

Expanded News Report:

Why: Quoin Pharmaceuticals is seeking to address the unmet medical need for treatments for Netherton Syndrome, a rare and debilitating genetic skin disorder. The company aims to accelerate the development and commercialization of its lead product candidate, QRX003, in Japan.

Who: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) is the primary entity involved. Key players include Dr. Michael myers,CEO of Quoin Pharmaceuticals,and the Ministry of Health,labour and Welfare (MHLW) of Japan.

What: Quoin Pharmaceuticals received confirmation from the MHLW that QRX003 qualifies for both Orphan Drug Designation (ODD) and Fast Track regulatory review in Japan for the treatment of Neth